PhD Position Decision-making Under Uncertainty for Emerging Orphan and Breakthrough Medical Devices

This four‑year doctoral project is part of the EU‑funded COMPASS4MD consortium at Delft University of Technology. The research investigates how regulatory actors assess uncertain clinical evidence for orphan and breakthrough devices and how future regulatory approaches can better handle that uncertainty. The candidate will review regulatory documents, interview assessors and other stakeholders, create realistic case scenarios, and evaluate regulatory sandboxes and conditional market access. The work involves close collaboration with European partners, organization of stakeholder workshops, and occasional travel within Europe. Successful applicants are expected to work independently on their research while contributing to consortium deliverables and reporting.

• Review European regulatory documents and public opinions on medical devices.
• Conduct interviews with notified‑body assessors, regulators, clinicians, patients and industry representatives.
• Develop realistic case scenarios that illustrate different types and levels of uncertainty.
• Organise and facilitate stakeholder workshops to discuss scenario outcomes.
• Analyse interview and workshop data to identify factors influencing acceptance of uncertainty.
• Produce recommendations for regulatory sandboxes, conditional market access and post‑market evidence generation.
• Contribute to consortium meetings, joint publications and deliverables across Europe.
• Travel within Europe to meet partners and attend workshops as required.